Friday, August 8, 2014

CASAA Submits Comment to FDA on Behalf of Consumers Regarding FDA Proposed Deeming Regulation

Last night, CASAA submitted its comment on behalf of consumers in connection with the FDA's proposed deeming regulation.  Following are a few highlights from the 53-page comment:

  • The proposed regulation is a de facto ban of more than 99% of the e-cigarette products currently on the market (something in the order of 100,000), creating an enormous cost to consumers.  In fact, the proposed regulation comes remarkably close to being all costs--very substantial ones--with no benefits.
    • The paperwork burdens are not about actual health, safety, or quality control issues and really provide no benefit to consumers.
    • The only products that will be able to successfully navigate the approval process will likely be the cigalike devices produced by the largest manufacturers.
  • The proposed regulation and accompanying publications by FDA are misleading, arbitrary and capricious for numerous reasons, and thus are not a legitimate basis for rulemaking.
    • The stated scientific background and impact analysis are fraught with omissions, bias, and errors.
    • The proposed regulation does not meet FDA’s own standards for showing that there will be a net public health benefit, and, in fact, there is overwhelming reason to believe the net public health effects will be negative.
  • For decades, it has been considered an ethical and political mandate for stakeholders to have a seat at the table in FDA rulemaking.  Yet consumers have been excluded from such a seat in the process.  
    • The slot on the TPSAC committee supposedly reserved for a consumer representative has been occupied by advocates who are not only not consumers of the products or representatives therefore, but whose political goals include eliminating consumption of the products, the diametric opposite of representing consumer interests.
    • Part of the explanation for FDA's apparent lack of understanding about the role e-cigarettes and other tobacco products play in consumers lives, as well as what will actually happen if these regulations are implemented, is the lack of consumer involvement in the process.
  • Consumers are better served by the current marketplace than they would be by the marketplace that would be created by the proposed deeming regulation.
  • If FDA wishes to do what is best for consumers, the primary stakeholders, it needs to either remove e-cigarettes from the proposed deeming or completely withdraw the proposed deeming regulation. FDA should then ask Congress to provide enabling legislation that would allow for genuinely beneficial regulation of e-cigarettes.
  • If FDA insists on moving forward with this type of devastating legislation, it is morally and legally obligated to:
    • Revise its scientific analysis so that it is complete, accurate, and unbiased;
    • Revise its impact analysis so that it actually assesses all of the impacts;
    • Assess and report the predictable real effects of the regulation (e.g., black markets);
    • Complete and report an analysis of the full public health effects of the regulation;
    • Include consumer representatives in the rulemaking process; and
    • Eliminate the unequal treatment of different social classes by giving "premium e-cigarettes" the same consideration granted to premium cigars.
While commenting on the proposed regulation is, of course, an important step in our fight against the deeming regulation, it is by no means our last.  We will be issuing a CQ Roll Call campaign in the next week directed at members of Congress as we continue with CASAA's Action Plan.

You may download and read CASAA's comment to the FDA here:

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